(165 days)
The Clear-Aligner system is indicated for the treatment of malocclusion in patients with permanent dentition. The Clear-Aligner system positions teeth by way of continuous gentle force.
A dental health care professional (e.q. orthodontist or dentist), using a standard personal computer prescribes the Clear-Aligner system based on an assessment of thee patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth, and completes a prescription form. Utilizing standard dental software used for tooth alignment, CDB then designs a series of plastic trays intended to gradually realign the patient's teeth in accordance with the physician's prescription. The prescribing physician reviews and approves the treatment plan before the molds are produced. Once approved, CDB produces the trays, which are formed of clear, thin, thermoformed, copolyester plastic. The trays sent back to the dental health care professional, who then provides them to the patient, confirming fit and design. Over a period of months, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the desired position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicates referenced in Table 1.
The provided text describes the acceptance criteria and study for the "Clear-Aligners" device. However, it does not detail a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study, as the device is a physical product (orthodontic aligners) rather than a diagnostic AI. The "performance testing" section refers to bench testing of the manufacturing process, not clinical performance for diagnostic accuracy.
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functional Characteristics: | |
| Fit of the aligner against the treatment plan as determined by a dental health professional | The acceptance results observed during verification and validation testing have shown that the devices are capable of performing to their stated intended use and specification requirements. |
| Process consistency from the treatment plan file to 3D printed mold to final aligner | Measured against internal acceptance criteria derived by considering all sources of variation. The acceptance results observed during verification and validation testing have shown that the devices are capable of performing to their stated intended use and specification requirements. |
| Biocompatibility Testing (for mucosal membrane contacting for >30 days): | |
| Cytotoxicity | Met the requirements of the study protocols; material is considered non-cytotoxic. |
| Sensitization | Met the requirements of the study protocols; material is considered non-sensitizing. |
| Irritation | Met the requirements of the study protocols; material is considered not an intracutaneous irritant. |
| Software Functionality (for ordering process and treatment planning): | Software usage is considered of moderate concern. Software testing has been performed to verify the function, supporting a substantial equivalence decision. (Specific performance metrics for software are not provided in this document). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly mention a "test set" in the context of clinical data, as this is a device for physical tooth alignment, not a diagnostic algorithm. The performance testing refers to bench testing for manufacturing and fit. Therefore, information on data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable or provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The performance testing involves "dental health professional" assessment of aligner fit, and manufacturing process consistency, not diagnostic expert consensus for a clinical ground truth.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of a diagnostic test set requiring adjudication.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such study was conducted or is applicable to this device, as it is a physical orthodontic aligner, not an AI-powered diagnostic tool. The document focuses on the substantial equivalence of the aligners themselves to predicate devices in terms of function, materials, and manufacturing process.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Clear-Aligners are a physical medical device. The software mentioned is for ordering and treatment planning, not for standalone diagnostic performance.
7. The Type of Ground Truth Used
For the functional characteristics (fit, process consistency), the "ground truth" seems to be the pre-established internal specification and acceptance criteria, along with assessment by a dental health professional. For biocompatibility, the ground truth is established by the results of standardized biological tests (Cytotoxicity, Sensitization, Irritation).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML algorithm for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Overall Study Information:
The study described is primarily focused on bench testing to ensure the manufacturing accuracy and functional characteristics of the Clear-Aligners, and biocompatibility testing of the materials used. The approach taken is to demonstrate substantial equivalence to already legally marketed predicate devices (Clear Correct and Invisalign) based on similar indications for use, technological characteristics, mechanism of action, materials, and performance. The document explicitly states: "Further testing was not performed given there is sufficient information available from the scientific literature and from the predicate devices to demonstrate that sequential aligners provide reasonable assurance of substantial equivalence."
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.